Effect of Fasting With Two Meals on Insulin Resistance Indices of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429390
• Other study ID #: 1345103
• Status: Completed
• Phase: N/A
• First received: January 29, 2007
• Last updated: January 30, 2007
• Start date: August 2006
• Est. completion date: November 2006

Study information

• Verified date: January 2007
• Source: Free Islamic University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

this study was conducted to assess the insulin resistance indices in the subjects undergoing Ramadan fasting (diet which consisted of two meals at 12 hours intervals)for a thirty days period.

Description:

Insulin resistance is a feature of a number of clinical disorders, including type 2 diabetes/glucose intolerance, obesity, dyslipidaemia and hypertension clustering in the so-called metabolic syndrome.The prevalence of the metabolic syndrome, as defined by the 2001 ATP III criteria, was 22 percent, with an age-dependent increase.Data demonstrates that the prevalence has continued to increase, particularly in women.Hyperinsulinemia occurring in response to insulin resistance may play an important role in the genesis of metabolic syndrome. Prevention or reduction of obesity, particularly abdominal obesity, is the main therapeutic goal in patients with the metabolic syndrome .Weight reduction is optimally achieved with a multimodality approach including diet, exercise, and possible pharmacologic therapy, as with orlistat .It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, by reducing insulin resistance may be effective in improving the metabolic syndrome .During the month of Ramadan (The ninth month of the Islamic calendar), Muslims fast every day from dawn to sunset. They refrain from drinking and eating for about 12h intervals. There are currently no reports on the effect of Ramadan fasting (only two meals per day) on metabolic syndrome. Therefore, this study was conducted to assess the insulin resistance indices in the subjects undergoing this type of fasting for a thirty days period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Males with metabolic syndrome

Exclusion Criteria:

Conditions with insulin resistance including:

• Type 2 diabetes mellitus

• Infections

• Stresses

• Uremia

• Acromegaly

• Glucocorticoid excess

• Hypertension

• Cirrhosis and;

• Any addiction or drug therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Ramadan Fasting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Free Islamic University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring insulin sensitivity in metabolic syndrome